ASTM International Committee E55 on Manufacture of Pharmaceutical

ASTM International Committee

E55 on Manufacture

of Pharmaceutical

Products

Christine DeJong, ASTM International

Graham Cook, Chairman of E55

Overview

• About ASTM International

• ASTM International Standard Development Process

• Technical Committee E55

• E55 Vision and Standards Roadmap

2

About ASTM International

• ASTM International – 110 year-old international not-for-profit organization that

develops consensus standards – including test methods

– Participation open to all - 30,000 technical experts from across the globe

• ASTM’s Objectives – Promote public health and safety

– Contribute to the reliability of materials, products, systems and services

– Facilitate national, regional, and international commerce

• ASTM Standards – Known for high technical quality

– Over 12,000 ASTM standards for more than 100 industry sectors

– 4,000 ASTM standards used in regulation or adopted as national standards around the world in at least 80 countries

International Standards

Principles

WTO / TBT Principles ASTM Principles

Transparency Transparency

Openness Openness

Impartiality and consensus

Impartiality and Consensus

Effectiveness and relevance

Effectiveness and relevance

Coherence Coherence

Consideration of developing nations

Consideration of developing nations

• Over 1500 ASTM members from Europe – Serving on 134 different technical Committee

• Chair of ASTM F40 on Declarable Substances and Materials from the Netherlands

– ASTM meetings in EU are increasing

• 17 percent of ASTM’s standards distributions are in the EU

• 500 ASTM references in EU legislation since 2001 – 85 legislative acts / 19 acts pending

ASTM in Europe

Overview





6

Open Forum for Consensus

Standards

• Forum

– Direct stakeholder involvement – Every member has equal say – Consensus-based procedures – Private and public sector – Cooperation – Balance of Interests – ensures

market relevance • Examples Manufacturers, Regulatory agencies, Associations,

Professional societies, Professionals and Consultants, Academia, Research Institutions and laboratories

Overview of Structure

• Technical Committees form to address specific industry subjects.

• Subcommittees are established to address subsets of specialized subject matter.

• Task Groups to write standards.

Main Committee

Subcommittee

.01

Subcommittee

.02

Subcommittee

.03

Task

Group 1

Task

Group 2

Initiation and Usage

Standards

• Need Identified in Industry, Marketplace, or Government

• Online balloting process requires high level consensus - 90% affirmative

• Voluntary unless referenced in

regulations or contract (ex. Aviation

standards in EASA)

Overview





10

E55 Scope and History

• Scope: development of standardized nomenclature and definitions of terms, recommended practices, guides, test methods, specifications, and performance standards for the manufacture of pharmaceutical products.

• Formed in 2003 under previous title “Pharmaceutical Application of Process Analytical Technology”

– Improve efficiency, process control, safety, and

ultimately, product quality and public health

• In 2006, E55 expanded to address all aspects of pharma, changing to current title “Manufacture of Pharmaceutical Products”

E55 Executive Committee &

Officers • Chair: Graham Cook, Pfizer UK

• Vice-chair: Paul Seo, FDA

• Secretary: James Rydzak, GSK, USA

• Membership Secretary: Gawayne Mahboubian-Jones, PMI Switzerland

• Members At Large

– Ken Leiper, Benson Associates, UK

– Riccardo Luigetti, EMA

– Peter McDonnell, Genzyme, UK

– Duncan Low, Amgen Inc, USA

• Subcommittee Chairs:

– Ali Afnan, Step Change Pharma Inc, USA

– Claus Weisemann, Alexion Pharamceuticals, USA

– Robert Steininger, Acceleron Pharma, USA

– Martin Warman, Vertex Pharmceuticals Inc, USA

– Paul Seo, FDA

– Chris Watts, NNE Pharmaplan, USA

– Philip Crooker, Shire Pharmaceuticals, USA

E55 Membership

• Diverse stakeholders – 175 members representing industry –

pharma, biopharma, suppliers; government; academia; SDOs; and general interest

• International Membership including – Australia, Belgium, Canada, Denmark, Finland,

Germany, Ireland, Italy, Japan, Korea, Mexico, Mongolia, Nepal, Netherlands, Portugal, Sweden, Switzerland, Singapore, United Kingdom & United States

Organization and Subcommittees

E55 Main

Committee

E55.01

PAT System Mgmt,

Implementation &

Practice

E55.03 General

Pharmaceutical

Standards

E55.04

General

Biopharmaceutical

Standards

E55.91

Terminology

E55.90

Executive

E55.92

Awards

E55.95

Roadmap

E55.94

Strategic Planning

& Resource

Development

Overview




• E55 Standards Roadmap and Vision

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E55 Standards Roadmap

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• Standards complement the global regulatory framework

• Not duplicative or competitive

• Add value for stakeholders

National/Regional Pharmacopoeias

ICH

Professional and Trade Associations;

Consortiums etc.

International Standards

(ASTM Intl.; ISO etc.)

National/Regional Regulations and Guidance

E55 Vision Statement

• Consensus standards can be differentiated from regulatory guidance and industry consortia publications. This differentiation enables consensus standards to add value by promoting a consistent yet flexible framework across product and process design, development, manufacturing and product performance through the product lifecycle.

• ASTM International Committee E55 on Manufacture of Pharmaceutical Products will create a portfolio of science and risk-based consensus standards. The Committee’s standards will describe sound scientific frameworks to facilitate pharmaceutical development, manufacture, and adherence to quality and performance criteria across the product lifecycle.

• Global stakeholders, including industry, academia, regulators, researchers, and consumers, will contribute to the development of ASTM E55 standards. ASTM Committee E55 will advance the global recognition, implementation, and acceptance of E55 standards. The most important criterion throughout development, implementation, and acceptance of the standard will be the technical suitability and relevance of the standard.

• In achieving ASTM E55’s objective of global application and relevance, the Committee will further ASTM International’s mission as a globally recognized standards development organization with individual members from over 135 World Trade Organization (WTO) member countries. ASTM’s standards development process is designed in accordance with the principles for international standards established by the WTO and allows individuals and governments to participate directly as equals, in a consensus-based manner.

• To facilitate global outreach and cooperation and educate about ASTM E55 standards’ global suitability and relevance, ASTM E55 will seek active liaison on a worldwide basis with all global stakeholders.

New Vision for E55

• Five elements:

– Added Value through differentiation from regulatory guidance and industry publications

– Universal – Standards for product and process design, development, manufacture, and performance through the product lifecycle

– Tangible output – portfolio of science- and risk-based Standards

– Global use – internationally recognized

– Outreach – liaison with stakeholders worldwide

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Discussion Points

• Role of Standards in supporting the supply of quality medicines worldwide

– Complex global supply chains

– Challenges for industry and regulators

• EMA participation in Standards development and balloting process

• Any questions about participation in E55.90 as a ‘Member at Large’?

• Moving forward

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Thank you!

Contact Information

Christine DeJong

ASTM International

E55 Manager, Technical Committee Operations

T: +1-610-832-9736

E: [email protected]

Graham Cook

Pfizer, UK

E55 Chairman

T:+44-(0)1628-692020

E: [email protected]

mailto:[email protected]

mailto:[email protected]

Back up Slides

Approved Standards 1. E2363 Standard Terminology Relating to Process Analytical

Technology in the Pharmaceutical Industry 2. E2474 Standard Practice for Pharmaceutical Process Design

Utilizing Process Analytical Technology 3. E2475 Standard Guide for Process Understanding Related to

Pharmaceutical Manufacture and Control 4. E2476 Standard Guide for Risk Assessment and Risk Control as it

Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

5. E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

6. E2503 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

7. E2537 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

8. E2629 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

9. E2656 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

10. E2810 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

Standards in Progress

1. WK12892 New Guide for Standard Guide for Process Sampling (Technical Contact: Joep Timmermans)

2. WK15778 / WK36060 New Guide for Guide for Science-based and Risk-based Cleaning Process Development and Validation (Technical Contact: Andrew Walsh)

3. WK16888 New Guide for Validation of PAT Methods (Technical Contact: James Rydzak)

4. WK28608 New Practice for Demonstrating Capability to Comply with USP Test for Uniformity of Dosage Units (Technical Contact: Thomas Murphy)

5. WK30195 / WK36086 New Guide for Particle analysis Applications in Pharmaceutical Processes including SUB-Visible particle analysis (Technical Contact: Thomas Canty)

6. WK34349 New Guide for the Application of Continuous Processing in the Pharmaceutical Industry (Technical Contact: Trevor Page)

7. WK36058 New Guide for Multivariate data analysis related to pharmaceutical development and manufacturing (Technical Contact: Chun Cai)

8. WK36552 New Practice for Process for Inactivation of Retrovirus by pH (Technical Contact: Ali Afnan)

mailto:[email protected]?subject=WK12892














Biopharmaceutical Standards: Characterization and Identification of Biological Systems, Unit Process and

Validation

1. E1285 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA 2. E1286 Standard Guide for Identification of Herpes Simplex Virus or Its DNA 3. E1298 Standard Guide for Determination of Purity, Impurities, and Contaminants in

Biological Drug Products 4. E1493 Standard Guide for Identification of Bacteriophage M13 or Its DNA 5. E1531 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by

Growth on Agarose Medium 6. E1532 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by

Use of Bisbenzamide DNA-Binding Fluorochrome 7. E1533 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-

Diamidino-2-2 Phenylindole (DAPI) Staining 8. E1536 Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by

Large Volume Method 9. E1564 Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities

for Maintaining Cryopreserved Biological Materials 10. E1565 Standard Guide for Inventory Control and Handling of Biological Material

Maintained at Low Temperatures 11. E1566 Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen 12. E1759 Standard Test Method for Isoaspartic Acid in Proteins: Method for the

Determination of Asparagine Deamidation Products 13. E1873 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain

Reaction Technique 14. E2048 Standard Guide for Detection of Nucleic Acids of the Mycobacterium Tuberculosis

Complex and Other Pathogenic Mycobacteria by the Polymerase Chain Reaction Technique

15. E1470 Standard Test Method for Characterization of Proteins by Electrophoretic Mobility 16. E2097 Standard Guide for Determining the Impact of Extractables from Non-Metallic

Materials on the Safety of Biotechnology Products

Relations with other SDO’s

• ASTM avoids duplication of efforts of our members

• Normatively reference documents where needed

• Committee establishes liaisons between organizations and related technical committees

• Regular reports during meetings to Executive and Main committee

• Industry determines needs and best services for market

USA: Use of Standards by

Federal Agencies

• National Technology Transfer and Advancement Act of 1995 (NTTAA) – Requires federal government agencies to use

standards developed by voluntary consensus standards organization when possible

– Encourages federal government agencies to participate in standards development organizations

• OMB Circular No. A-119 – http://standards.gov/a119.cfm – Reinforces goals of National Technology

Transfer and Advancement Act – Discourages federal agencies from using

government-unique standards

http://standards.gov/a119.cfm

Types of Standards

• Company Standard

• Consensus among the employees of an organization.

• Consortium Standard

• Consensus among a small group of organizations; like-minded companies undertaking an activity to collectively conserve resources.

• Industry Standard

• Consensus among the many companies within an association or society.

• Government Standard

• Multiple degrees of consensus. Some written by individuals within agencies, sometimes developed with private sector then adopted by reference as mandatory.

• Voluntary Consensus Standard

• Consensus is developed by representatives of all sectors that have an interest in the use of the standard (producers, users, and those having a general interest, consumers). Consensus standards, with their broad input, are considered by many as the most technically sound and credible documents. They are often used as the basis for commercial and regulatory action.

Documents

ASTM International Committee E55 on Manufacture of Pharmaceutical